Three position needle retraction

ABSTRACT

In some embodiments a system and method are described for safeguarding a hazard, the hazard, for example a needle point, may be moved between a protected retracted position, an active extended position and/or an intermediate position. Optionally in the retracted position, the hazard may be protected inside a housing. Optionally in the extended position, the hazard may be exposed. Optionally, in the intermediate position the hazard may be partially protected and/or concealed, for example by a shield and/or in an indentation. In some embodiments, compromising a shield causes the hazard to be retracted to the retracted position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a section 371 of International Application No.PCT/US17/35486, filed Jun. 1, 2017, which was published Dec. 7, 2017under International Publication No. WO 2017/210448 A1, which claims thebenefit of U.S. Provisional Application No. 62/344,782, filed Jun. 2,2016, the disclosures of which are incorporated herein by reference.

RELATED APPLICATION/S Field and Background of the Invention

The present invention, in some embodiments thereof, relates to a needleextension and/or retraction mechanism and, more particularly, but notexclusively, to a mechanism for protecting a needle tip from stickhazards after removal of an autoinjector for example a patch injectorfrom a subject.

U.S. Pat. No. 8,915,882 relates to “A needle assembly adapted for fluidcommunication with a vial containing a substance to be delivered to asubject, the needle assembly including a needle held in a needle holder,the needle holder confined to move in a housing, and an activationmechanism for activating delivery of the substance through the needle,the activation mechanism including a safety latch that initially impedesmovement of the needle holder, wherein when the safety latch is placedon the subject, the safety latch moves to a position that permits movingthe needle holder to cause the needle to protrude outwards of thehousing to pierce the subject to allow administration of the substanceto the subject.”

U.S. Pat. No. 8,152,779 relates to “A needle assembly adapted for fluidcommunication with a cartridge containing a substance to be delivered toa subject, the needle assembly characterized by a biasing device (70)arranged to apply a biasing force on a needle (28, 116) to cause theneedle (28, 116) to protrude outwards of a housing (30, 112) to piercethe subject, and biasing device release apparatus (60) including abiasing device arrester (62) that initially blocks movement of thebiasing device (70) and which releases the biasing device (70) when thesafety latch (32, 122) moves to a position that permits moving theneedle holder (26, 118) to cause the needle (28, 116) to protrudeoutwards of the housing (30, 112).”

U.S. Pat. No. 7,530,964 relates to a needle device that, “has a needleretraction mechanism that retracts the needle upon removing the devicefrom the skin surface (either intentionally or unintentionally). Oncethe needle is retracted, the device is rendered inoperative. The needlecan be further made inoperative by bending it when one attempts to reusethe device. In another embodiment, a needle opening formed in the baseof the housing can be covered to render the needle inoperative when oneattempts to reuse the device. In another embodiment, the needle deviceinstead has a needle shield that automatically covers the needle afteruse.”

U.S. Pat. No. 9,072,827 relates to a method and device “for preventing aneedle stick hazard in the event of a collapse of a protective needleflap of a portable drug pump. The device may include a needle guide, asecure space and/or a shield. A point of a needle is optionallydeflected into a secure space upon collapse of the protective flap. Thespace may optionally be shielded. Optionally, the support linking theneedle to the pump may pivot and/or translate. Optionally, there may bean exposing position wherein the needle protrudes through an opening inthe flap. Optionally, the opening may be non-circular.”

U.S. Pat. No. 7,530,964 relates to a needle device which, “has a needleretraction mechanism that retracts the needle upon removing the devicefrom the skin surface (either intentionally or unintentionally). Oncethe needle is retracted, the device is rendered inoperative. The needlecan be further made inoperative by bending it when one attempts to reusethe device. In another embodiment, a needle opening formed in the baseof the housing can be covered to render the needle inoperative when oneattempts to reuse the device. In another embodiment, the needle deviceinstead has a needle shield that automatically covers the needle afteruse.”

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the invention, there isprovided a device for protecting a sharp tip of a hollow needleincluding: a housing including an inner side and an outer side and anopening between the inner side and the outer side; a needle mountmovably connecting the needle to the housing for a movement through theopening between a retracted position wherein the sharp tip is inward ofthe outer side of the housing and an extended position wherein the sharptip projects outward from the outer side of the housing; a needleshield, shielding the sharp tip of the needle in the extended position;a lock on the mount inhibiting movement of the needle from the extendedposition to the retracted position; and a mechanical interlock betweenthe shield and the lock, the interlock releasing the lock to allowretraction of the needle from the extended position to the retractedposition when the needle shield is compromised.

According to some embodiments of the invention, the movement of theneedle between the extended position and the retracted position isapproximately directed along an axis of the needle.

According to some embodiments of the invention, when the needle tip ispositioned between the shield and the housing during the shielding.

According to some embodiments of the invention, the compromisingincludes movement of the shield with respect to the housing during theshielding.

According to some embodiments of the invention, the movement of theneedle shield is toward the housing.

According to some embodiments of the invention, the movement of theneedle shield is toward the opening.

According to some embodiments of the invention, the compromisingincludes exerting a force of at least 1 N on the shield.

According to some embodiments of the invention, the force is at leastpartially directed toward the housing.

According to some embodiments of the invention, the needle shield ispivotally mounted on the housing about a pivot and in the shieldingconfiguration the needle shield is pivoted away from the housing.

According to some embodiments of the invention, the shield is movablymounted on the housing for movement between a primed position and ashielding position and the shield includes a needle opening, and whereinin the primed position, the needle tip is aligned to pass through theneedle opening during the movement from the retracted position to theextended position and in the shielding position the needle tip isblocked by a portion of the shield.

According to some embodiments of the invention, the needle shield ismovable mounted on the housing between a first position wherein theneedle shield is flush with the housing and a shielding position whereinthe shield is shielding the sharp tip.

According to some embodiments of the invention, the needle shield isbiased toward the shielding position by a biasing device.

According to some embodiments of the invention, the outer side of thehousing includes an adhesive skin contact area.

According to some embodiments of the invention, the opening is withinthe adhesive skin contact area.

According to an aspect of some embodiments of the invention, there isprovided a method of safeguarding a needle point of a drug dischargedevice the device including a housing base including a contact side andan opposite side and an opening between the contact side and theopposite side; the method including: providing the drug discharge devicewith the contact side of the base contacting an injection surface andthe needle point locked in an extended position protruding from thecontact side of the device into an injection surface; deploying a needleshield to a deployed position in response to a distancing of the basefrom the injection surface; wherein in the deployed position wherein theextended position of the needle point is between the base and the needleshield; sensing a compromising of the needle shield after the deploying;and unlocking the needle from the extended position in response to thesensing.

According to some embodiments of the invention, the method furtherincludes: automatically retracting the needle to a retracted position onthe opposite side of the base in response to the sensing.

According to some embodiments of the invention, the needle shield ismechanically interlocked with a locking mechanism such that a movementof the needle shield from the deployed position triggers the unlocking.

According to an aspect of some embodiments of the invention, there isprovided a method of safeguarding a needle point of a drug dischargedevice the device including a housing base including a contact side andan opposite side and an opening between the contact side and theopposite side; the method including: providing the drug discharge devicewith the contact side of the base contacting an injection surface andthe needle point in an extended position protruding from the contactside of the device into an injection surface; deploying a needle shieldto a deployed position in response to a distancing of the base from theinjection surface; wherein in the deployed position wherein the extendedposition of the needle point is between the base and the needle shield;sensing a compromising of the needle shield after the deploying; andretracting the needle to a retracted position on the opposite side ofthe base in response to the sensing.

According to an aspect of some embodiments of the invention, there isprovided a needle device including: housing base including an openingbetween an inner side of the base and an outer side of the base oppositethe inner side; a needle point mounted for a movement through theopening between a retracted position inward of the inner side of thebase and an extended position outward from the outer side of the base; aneedle shield having a shielding configuration in which a tip of theneedle in the extended position is positioned on the outer side betweenthe base and the needle shield; and a retraction mechanism mechanicallyinterlocked to the needle shield to move the needle from the extendedposition to the retracted position in response to a compromising of theneedle shield.

According to some embodiments of the invention, the outer side of thebase includes an adhesive skin contact area.

According to some embodiments of the invention, the compromisingincludes movement of the shield from the shielded configuration.

According to some embodiments of the invention, the compromisingincludes exerting a force of at least 1 N on the shield.

According to some embodiments of the invention, the shield has a firstposition wherein the needle is aligned to pass through the needleopening and a second position wherein the shield is moved with respectto the housing and the needle is blocked by a portion of the shield.

According to some embodiments of the invention, the needle shield ispivotally mounted on the housing about a pivot and in the shieldingconfiguration the needle shield is pivoted away from the housing.

According to some embodiments of the invention, the needle shield ispivotally mounted on the housing about a pivot and in the first positionthe needle shield is flush with the housing.

According to some embodiments of the invention, the needle shield isbiased toward the shielding position by a biasing device.

According to some embodiments of the invention, the movement of theneedle shield is toward the base.

According to some embodiments of the invention, the force is at leastpartially directed toward the base.

According to an aspect of some embodiments of the invention, there isprovided a needle device including: housing base including an openingbetween an inner side of the base and an outer side of the base oppositethe inner side, the outer side including a skin contact area; a needlepoint mounted for a movement through the opening between a retractedposition inward of the inner side of the base and an extended positionoutward from the outer side of the base; a lock mechanism that locks theneedle in an intermediate position wherein the needle point ispositioned along a path of the movement between 10% to 90% of thedistance between the retracted and the extended position.

According to some embodiments of the invention, the needle devicefurther includes: a needle shield movable to a shielding configurationin which a tip of the needle is in the intermediate position and ispositioned between the base and the needle shield; and a retractionmechanism mechanically interlocked to the needle shield to move theneedle from the extended position to the intermediate position when theneedle shield is moved to the shielding position.

According to an aspect of some embodiments of the invention, there isprovided a method of safeguarding a hazardous component of a drugdelivery device the device including a housing base including an openingbetween an inner side of the base and an outer side of the base oppositethe inner side, the outer side including a skin contact area; the methodincluding: supplying the device with the hazardous component in a firstretracted position; extending the hazardous component in response to anexternal trigger from the first retracted position to an extendedposition protruding outward from the outer side of the base; locking thehazardous component in the extended position; delivering the drug withthe hazardous component in the extended position; retracting thehazardous component from the extended position to a second retractedposition at least 1 mm distant from the first retracted position;holding the hazardous component in the second retracted position.

According to some embodiments of the invention, the hazardous componentincludes a sharp tip of a needle the method further including shieldingthe sharp tip by a housing of the device in at least one of the firstretracted position and the second retracted position.

According to some embodiments of the invention, the hazardous componentincludes a sharp tip of a hollow needle and wherein the delivering isthrough a channel of the hollow needle.

According to some embodiments of the invention, the holding is for atleast 1 second.

According to some embodiments of the invention, the holdingindefinitely.

According to some embodiments of the invention, the method furtherincludes: releasing the holding in response to an external stimulus.

According to some embodiments of the invention, the external stimulusincludes a compromising of a needle shield.

According to some embodiments of the invention, the retracting is inresponse to an end of the delivering.

According to some embodiments of the invention, the retracting is inresponse to an external stimulus.

According to some embodiments of the invention, the external stimulusincludes a distancing of the delivery device from a skin of a user.

According to some embodiments of the invention, the second retractedposition is on the outer side of the base and the first retractedposition is on the inner side of the base.

According to some embodiments of the invention, the method furtherincludes: retracting the hazardous component from the second retractedposition to a third position on the inner side of the base.

According to some embodiments of the invention, the third position issubstantially the same as the first position.

According to some embodiments of the invention, the further retractingis in response to an external stimulus.

According to some embodiments of the invention, the external stimulusincludes compromise a shield of the hazardous component.

According to some embodiments of the invention, the method furtherincludes: deploying a shield after the delivering to shield thehazardous component in the second retracted position.

According to some embodiments of the invention, the further retractingoccurs automatically after a time delay after the retracting.

According to some embodiments of the invention, the second retractedposition is intermediate between 10% to 90% along a path of motionbetween the extended position and the first retracted position.

According to some embodiments of the invention, the first retractedposition is intermediate between 10% to 90% along a path of motionbetween the extended position and the second retracted position.

According to some embodiments of the invention, the method furtherincludes: providing a retraction mechanism for the retracting and asensor, the sensor mechanically interconnected to the retractionmechanism; moving the sensor in response to a distancing of the deliverydevice from the skin of a user; triggering automatically the retractingby the moving.

According to some embodiments of the invention, in the extended positionthe hazardous component protrudes outside the housing through an openingat least 2 mm from the opening and in the intermediate position thehazardous component protrudes outside the housing through an opening nomore than 1 mm.

According to some embodiments of the invention, the method furtherincludes: deploying a shield while the hazardous component is in thesecond retracted position such that the hazardous component is locatedbetween the shield and a surface of the outer side of the base.

According to some embodiments of the invention, the deploying istriggered by the moving of the sensor.

According to some embodiments of the invention, the holding includesblocking movement of the hazardous component from the second retractedposition by a mechanical interconnecting between the sensor and theretraction mechanism.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a flow chart illustration of a method of partially retractinga needle in accordance with an embodiment of the current invention;

FIG. 2 is a flow chart illustration of a method of shielding andretracting a needle in accordance with an embodiment of the currentinvention;

FIG. 3 is a flow chart illustration of a method of using and retractinga needle in accordance with an embodiment of the current invention;

FIG. 4 is a state diagram illustration of a partially retractable needlein accordance with an embodiment of the current invention;

FIG. 5 is a state diagram illustration of a needle in accordance with anembodiment of the current invention;

FIG. 6 is a state diagram illustration of a multi-position needle inaccordance with an embodiment of the current invention;

FIG. 7 is a block diagram illustration of a partially retractable needlein accordance with an embodiment of the current invention;

FIG. 8 is a block diagram illustration of a needle mechanism inaccordance with an embodiment of the current invention;

FIG. 9 is a perspective cutaway cross sectional illustration of amultistate needle insertion and protection system in a preactivatedstate in accordance with an embodiment of the current invention;

FIG. 10 is a perspective cutaway cross sectional illustration of amechanism holding a needle in a preactivated state in accordance with anembodiment of the current invention;

FIGS. 11A-11C are a perspective cutaway and cross sectionalillustrations of a needle mechanism in a primed state in accordance withan embodiment of the current invention;

FIGS. 12A-12D are a perspective cutaway and cross sectionalillustrations of a needle mechanism in an active state in accordancewith an embodiment of the current invention;

FIGS. 13A-13C are perspective cutaway illustrations of a mechanismholding a needle in an intermediate state in accordance with anembodiment of the current invention;

FIG. 14 is a perspective cutaway illustration of a mechanism holding aneedle in a retracted state in accordance with an embodiment of thecurrent invention;

FIG. 15 is a perspective cutaway illustration of a mechanism in anactivated state in accordance with an embodiment of the currentinvention;

FIG. 16 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention;

FIG. 17 is a perspective cutaway illustration of a mechanism in anactive state in accordance with an embodiment of the current invention;

FIG. 18 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention;

FIG. 19 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention;

FIG. 20 is a schematic illustration of dual rotating needle shields inaccordance with an embodiment of the current invention;

FIGS. 21A and 21B are schematic illustrations of a combination ofrotating and translating needle shields in accordance with an embodimentof the current invention;

FIG. 22 is a schematic illustration of a needle protection latch inaccordance with an embodiment of the current invention;

FIG. 23 is a schematic illustration of a translating needle shield inaccordance with an embodiment of the current invention; and

FIGS. 24A-24C are a schematic illustrations of a needle protectionmechanism in accordance with an embodiment of the current invention;

FIGS. 25A and 25B illustrate a sliding needle shield in accordance withan embodiment of the current invention;

FIG. 26A is a perspective view of a needle mechanism in a preactivatedlocked state in accordance with an embodiment of the current invention;

FIG. 26B is a perspective view of a needle mechanism in a primedunlocked state in accordance with an embodiment of the currentinvention;

FIG. 26C is a cutaway view of a needle mechanism in accordance with anembodiment of the current invention;

FIGS. 27A to 27C illustrate a needle assembly in a primed state inaccordance with an embodiment of the current invention;

FIGS. 28A to 28C illustrate a needle assembly in an activated state inaccordance with an embodiment of the current invention;

FIGS. 29A-29C illustrate a needle retraction mechanism in a partiallyprotected state in accordance with an embodiment of the currentinvention and

FIGS. 30A-30C illustrate a needle retraction mechanism in a fullyprotected state in accordance with an embodiment of the currentinvention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to a needleextension and/or retraction mechanism and, more particularly, but notexclusively, to a mechanism for protecting a needle tip from stickhazards after removal of an autoinjector for example a patch injectorfrom a subject.

Overview

An aspect of some embodiments of the present invention relates to anautoinjector with a needle that automatically partially retracts whenthe injector is removed from the skin of a subject. In some embodiments,an injector needle extends to an active position with an exposed portionof the needle extending outward from a skin contact surface and/or froman opening of a base of a housing of the injector. Optionally, in thepartially retracted state a smaller portion of the needle extendsoutward from the skin contact surface and/or the opening. Optionally thesmaller portion of the needle is covered by a shield for example toavoid a stick hazard.

In some embodiments a sensor may be stimulated by an external event, forexample, a sensor registers when the injector is placed onto and/ordistanced from the skin of a subject. Optionally, sensor output triggersneedle retraction and/or unlocks the needle from the extended position.For example, the sensor may include a mechanical component in contactwith the skin and/or mechanically interconnected to a needle retractionmechanism and/or a needle locking mechanism. For example, the mechanicalconnection may lock the needle in the extended position when the sensoris against the skin. Distancing a portion of the injector from the skinoptionally releases the mechanical interconnection to unlock the needleand/or to trigger partial retraction of the needle.

In some embodiments, reexposure of a needle is inhibited. For example,after retraction, a locking mechanism may prevent the needle from beingreextended. Alternatively or additionally, a shield may be deployedblocking the needle. Optionally the shield may be locked in placepreventing reexposure of the needle. Alternatively or additionally,further excitation of the sensor (for example moving the sensor) maycause and/or allow further retraction of the needle to a protectedlocation. Alternatively or additionally, a needle may retract, lockand/or unlock in connection to an event and/or status of the injector,for example, when all of a payload has been discharged and/or when thereis an occlusion in the system and/or in response to a user action and/orafter a time lapse.

In some embodiments a device may include a needle retraction mechanismand/or a needle shield. For example, the skin sensor may be designed toshield the needle and/or prevent a stick hazard. Optionally the shieldmay be deployed when delivery finishes and/or when the device isdistanced from an injection surface (e.g. the skin of a user).Optionally or additionally, the shield may protect the needle when theneedle is in an intermediate position. For example the shield and/orsensor may have the form of a flap covering the needle point and/or asleeve surrounding the needle point.

In some embodiments a needle may be held in a partially retractedposition for a time period. For example, the needle may be held in thepartially retracted position for between 0.1 sec to 1 sec and/or between1 sec to 5 sec and/or between 5 sec. to 20 sec and/or longer.Alternatively or additionally, the needle may be held until an externalstimulus causes it to be released. For example the external stimulus mayinclude a force exerted on an element of the drug delivery device. Forexample the needle may be released in response to a force on a needleshield and/or a force on the needle and/or a movement of the needleshield.

In some embodiments, a needle may be retracted from an extended positionto an intermediate position and/or a fully retracted position inresponse to an external stimulus. For example, the needle may beretracted in response to the delivery device being distanced from aninjection surface (for example the skin of a subject). For example theneedle may be retracted in response to removal of a skin contact surfaceof the device from the injection surface. For example the needle may beretracted in response to an action of a user, for example pushing aretraction button. Alternatively or additionally the needle may beremoved in response to a status of the delivery device. For example, theneedle may be retracted when the device completes delivery of aprescribed dose and/or upon a malfunction of the device.

An aspect of some embodiments of the present invention relates to amulti-level safety mechanism to protect a needle. In some embodiments,the safety mechanism includes a first component that protects the needleand a second component that is activated in response to changes in thefirst component. For example, a needle shield in a deployedconfiguration may block a sharp tip of the needle. When the needleshield is compromised, for example, a force is applied to the shieldand/or the shield moves from the deployed configuration, the needle isoptionally neutralized. For example the needle may be retracted and/orfolded and/or moved to a protected position.

In some embodiments a mount connecting a needle to a drug deliverydevice may include a needle retraction system and/or multiple protectionmeasures and/or a redundant needle protection system. Optionally, theneedle mount may allow movement of the needle with respect to thehousing. For example, the housing may include a skin contact surfaceand/or a needle opening in the skin contact surface. Optionally, theneedle is mounted to the housing to allow movement of needle in alongitudinal directional and/or movements that are nearly longitudinal(for example around a pivot approximately perpendicular to and/or farfrom the needle [for example the distance to the fulcrum may be morethan 4 times the length of the needle]). Optionally, a point of theneedle moves from a location inside the housing to a location outsidethe housing. For example, the needle point may pass through the needleopening. Optionally the housing may include a skin contact surface. Insome embodiments, the needle opening may pass through the skin contactsurface. Optionally the skin contact surface includes an adhesive forattachment to an injection site on a subject. In some embodiments, theneedle is hollow. For example, an end of the needle opposite the tip maybe connected to a drug reservoir. For example, the needle may beextended into the skin of a subject and/or the needle may act as a fluidpath for injecting the drug from the reservoir into the subject.

In some embodiments, an interconnection between a needle shield and aretraction mechanism may lock the needle in the extended and/orpartially retracted position. For example, the needle may be locked inthe extended and/or partially retracted position while the needle shieldis deployed. Movement of the needle shield may release the lock andallow the needle to be further retracted. In some embodiments, theneedle may retract automatically. Alternatively or additionally, theneedle may be unlocked and/or retract in response to an external force.For example, the needle shield may be interlocked with the needleretraction mechanism such that a force on the needle shield istranslated to a force pulling back the needle to a retracted and/orprotected position. Alternatively or additionally, the needle shield mayhave a natural path of movement, for example a path of least resistanceto movement that intersects the needle. Movement of the shield along thepath optionally causes the shield to contact the needle. Contact betweenthe shield and the needle optionally neutralizes the needle, for exampleby bending the needle and/or pushing it into a protected position.

An aspect of some embodiments of the current invention relates to aneedle having 3 or more stable positions. For example, a needle may havea retracted position, an extended position and/or third position. Forexample, the third position may include a partially retracted positionand/or an intermediate position between the extended and retractedpositions. Optionally, in the partially retracted position the needlemay be entirely retracted into a housing of the device. Alternatively oradditionally, in the partially retracted position, a portion of theneedle may extend out of the housing. For example the portion of theneedle extending out of the housing in the partially retracted positionmay be shorter than the portion extending out in the extended position.

In some embodiments, a needle retraction mechanism may be locked and/orunlocked and/or triggered by a skin sensor. Optionally, the skin sensormay be mechanically interlocked with the needle retraction mechanism.For example, when the sensor detects removal from the skin, the needlemay be unlocked from an extended position. Alternatively oradditionally, when the sensor detects removal from the skin, the needlemay be automatically retracted to a partially and/or fully retractedposition. For example, when the sensor detects removal from the skin theneedle retraction mechanism may be moved to and/or locked to a partiallyand/or fully retracted position. Alternatively or additionally, otherevents may lock, unlock and/or automatically move the needle retractionmechanism between positions.

In some embodiments, in an active state, a sharp needle and/or cannulamay extend out of the device. In a safeguarded state, the needle isoptionally partially retracted. For example, in the extended state aportion of the needle may be exposed and/or extend outside a housing ofthe device. Optionally, in the partially retracted state, a smallerportion of the needle may be exposed and or extend out of the devicethan in the extended state. For example, in the extended state a needletip may extend a distance away from a housing of the device. Optionally,in the partially retracted state, the needle may extend away from thedevice less than in the exposed state. Optionally, the device may have afully retracted state and an intermediate state. In the intermediatestate the needle may be on a path between the fully retracted state andthe extended state. For example, during injection a needle may extend adistance ranging for example between 2 to 5 mm and/or 5 to 8 mm and/or 8to 12 mm out of the skin contact surface. In the partially retractedstate a needle may extend a distance ranging between 20 to 70% and/or 70to 85% and/or 85 to 95% of the fully extended distance. Optionally, inthe partially retracted state the point of the needle may be locatedranging for example between 0.5 to 1 mm and/or 1 mm to 3 mm and/or 3 mmto 5 mm and/or 5 to 10 mm outward from the position in the fullyretracted state. Needle gauge may range for example between 34 to 30 Gand/or 30 G to 26 G and/or 26 to 22 G. The needle retraction stroke isoptionally at least 1 mm longer than needle extended length. Optionallythe needle may be extended by a spring driven mechanism. For example theforce exerted by the spring at the needle may range between 20 to 40 gr(grams force) and between 40 to 80 gr and/or greater than 80 gr.

DETAILED EMBODIMENTS

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Referring now to the figures, FIG. 1 is a flow chart illustration of amethod of partially protecting a hazardous element in accordance with anembodiment of the current invention. In some embodiments, a hazardouselement includes a sharp hazard and/or a biohazard and/or burn hazardand/or a toxic hazard and/or a chemical hazard (e.g. corrosive). Forexample a tip of a tube and or a needle may include a sharp hazard. Thetube is optionally locked 101 in an extended position. A sensor isoptionally mechanically interconnected with a locking mechanism.Stimulating 102 the sensor optionally causes releasing of the lockallowing the needle to be retracted 104 from the extended position to anintermediate position.

In some embodiments a tube (for example a needle and/or a cannula) maybe used for discharging a drug into a patient. The tube may be locked101 in an extended position, for example during discharge.

In some embodiments, drug discharge device will include a sensor. Forexample a sensor may be stimulated 102 when a device is removed from apatient. For example, a mechanical sensor may be biased to move outward.Outward movement of the sensor may be blocked when the device is on aninjection surface, for example on the skin of the subject. When thedevice is removed from the surface, the sensor may be released and/ormove. Alternatively or additionally a sensor sense light and/or maysense heat and/or conductivity of the surface. When the sensor isstimulated 102 for example detecting that the device was removed fromthe surface, the detector may unlock the tube allowing it to retract 104from the extended state. Alternatively or additionally, when the sensordetects 102 that the device was removed from the surface, the sensor maytrigger retraction of the tube. Alternatively or additionally, when the,when sensor detects that the device was removed from the surface, it maylock a needle retraction mechanism inhibiting the needle from moving tosome position. For example, the needle may be inhibited from reaching afully retracted position. For example the needle may be inhibited fromreturning to the extended position. Alternatively or additionally, asensor may include a sensor of a state of the injection device, forexample finishing of discharge and/or a malfunction.

FIG. 2 is a flow chart illustration of a method of neutralizing a hazardin accordance with an embodiment of the current invention. For example,the hazard may be a stick hazard from a needle point. For example, asystem may include a safety backup in case a first neutralizingmechanism is compromised. In some embodiments a needle may beneutralized by shielding 208 the needle. Optionally, the needle may bemoved 205 for example to a protected position when the functioning ofthe shield is compromised 210, for example by tampering with the shield.For example, compromising a shield may include applying a force to ashield. For example the force may be directed in a failure direction(for example a collapse direction and/or an opening direction). Theforce may range for example between 10 gr to 100 gr and/or 100 gr to1000 gr and/or 1000 gr to 5000 gr and/or 5000 gr to 10000 gr.Compromising a shield may include, for example, moving a shield withrespect to a hazard and/or a housing. For example, movement of theshield may include, at the point on the shied of maximum movement,movement of between 0.1 mm and 1 mm and/or between 1 mm and 5 mm and/orbetween 5 mm and 2 cm and/or more than 2 cm.

In some embodiments, allowing the needle to move 205 may includeretracting the needle to a protected location. Alternatively oradditionally, the needle may be allowed to move and/or fold, for exampleby unlocking a retraction mechanism and/or a needle holder. For example,once the shield is unlocked, if the shield fails, for example collapses,the shield may cause the needle to collapse and/or be neutralized.

In some embodiments, compromising 210 the shield may include applying aforce to the shield. For example when a force is applied pushing theshield towards a collapsed state and/or pulling a shield away from theshielding position, movement 205 of the needle may be triggered. Forexample when a force is applied to the shield by an object pushingitself between the shield and the needle, movement 205 of the needle maybe triggered.

In some embodiments, a shield may be deployed 208 while a needle in anextended position. Optionally a needle may be locked into an extendedposition while discharging a drug into a subject. For example, afterdischarge and/or after removal of the discharge device from the subject,a shield may be deployed 208 while the needle remains in the extendedposition. Alternatively or additionally, shield may be deployed 208while a needle is in an intermediate position. For example, at the endof discharge and/or when the device is removed, a needle may bepartially retracted and/or the shield may be deployed to protect theneedle in the partially retracted position.

FIG. 3 is a flow chart illustration of a method of using and/orretracting a tube in accordance with an embodiment of the currentinvention. In some embodiments, a device may include an automatic tubeinsertion and/or stick hazard protection system. Optionally, the devicemay have multiple stages of extension and retraction. For example, anextension mechanism may insert the tube (for example a hypodermicneedle) into a subject. For example, a shield may cover the needleand/or ameliorate a stick hazard. For example, a retraction mechanismmay move a needle to a fully and/or partially protected position. Theshielding and/or retracting are optionally integrated. Optionally,deployment and/or withdrawal of a shield may be triggered by a sensorand/or by a state of the device and/or by a user action. Optionally,extension and/or retraction of a needle may be triggered by a sensorand/or a state of the device and/or a user action. For example,integrated movements of the shield and/or needle may facilitate needleinsertion, drug discharges and/or protection against a stick hazard. Insome embodiments, a single component may serve multiple functions. Forexample a sensor may also shield a needle and/or a retraction mechanismmay also serve as a sensor. Note that FIG. 3 illustrates a large numberof actions. Some actions of the method may be performed independently ofothers. Some of the actions may be performed in the absence of others.

In some embodiments, an injector may be prepared 312 for use. Forexample, preparing 312 an injector for use may include deploying a skinsensor. Optionally an injector is supplied to a user in a stored state.For example, unwrapping the device (for example removing it from ablister package, removing a protective adhesive covering and/or removinga battery isolator) may prepare 312 the device for use. For example,removing the device from a blister package may uncover a sensor and/oractivate a mechanical sensor. For example a mechanical skin sensor maybe freed to deploy from the base of the device as the device is liftedfrom a blister package and/or when an adhesive cover is removed from thebase.

In some embodiments, an injector may be placed 312 onto an injectionsurface, for example the skin of a subject. Optionally, a sensor mayregister 314 placement 313 of the device. For example, a mechanicalsensor may register contact with the surface. Alternatively oradditionally, the sensor may be operative to register a quality of theplacement 313 of the device. For example, a sensor may register 314 thetemperature and/or conductivity of the surface and/or a sensor mayregister 314 the distance from a point on the injection surface to apoint on the injector and/or whether a position of the injector withrespect to the surface is stable and/or changes. For example, if thedistance between the sensor location and the injector surface is notstable, the device may alert the user that the device is improperlyplaced. Exemplary sensors that might be used and/or have potential todetect proper placement on the skin include for example: capacitance,magnetic and/or optic. Optionally, based on output of one or moresensors, a controller may confirm that a needle shield is closed and/orthat the device has established contact with skin.

In some embodiments, a device may be primed 315 before use. For example,priming may be performed automatically when the proper placement 313 ofthe device is registered. For example, a mechanical sensor may beinterconnected with a needle extension mechanism. For example, placement313 of the device on the skin of a subject may cause movement of thesensor and/or movement of the sensor may unlock the needle extensionmechanism. Optionally the priming of the system, for example unlockingof the needle extension mechanism, occurs automatically in response toregistering 314 of the sensor. Alternatively or additionally, thepriming of the system may require a user action (for example pushing anOK button once the device has been properly placed 313).

In some embodiments, a device may be activated 316 by a user action. Forexample, once the device has been placed 313 and/or primed 315, a usermay press a button to trigger needle extension 318. Optionally theneedle extends out of the base of the device and/or into the skin of thesubject. In some embodiments, a needle may be hollow and/or a drug maybe injected through the needle. Alternatively or additionally, afterinsertion a needle may be removed leaving behind a tube (for example acannula) for discharge 301 of a drug. Alternatively or addition,movement of the sensor may automatically trigger activation of thedevice and/or needle extension 318. Alternatively or additionally, auser may manually extend 318 the needle (for example the user may pushagainst a surface which drives the needle into his skin). Optionally, adrug may be discharged 301 through the needle into the subject.

In some embodiments, a user may remove 320 a device from a surface. Forexample after discharge 301 of the drug, a user may remove 320 thedevice from his skin. Alternatively or additionally, a user may remove320 the device before discharge has completed (e.g. prematurely).Alternatively or additionally, a user may remove 320 the device when amalfunction occurs. Optionally a sensor may register 302 removal of thedevice.

In some embodiments, in response to registering 302 removal of thedevice from the skin, the device may be safeguarded. Alternatively oradditionally the device may be safeguarded in response to a completionof discharging and/or a malfunction. Optionally, safeguarding the deviceincludes neutralizing a stick hazard. For example, a delivery tube (e.g.a needle) may be partially retracted 304 and/or a shield may be deployed308. For example, in the deployed state, the shield may cover the tip ofthe needle. For example the shield may deploy 308 to cover the tip ofthe needle while the needle is in the partially retracted 304 state. Insome embodiments, a skin sensor may include a needle shield.

In some embodiments, a safeguard mechanism may include a redundantand/or failsafe protection mechanism. For example, a needle may includea further retraction 305 mechanism that moves the needle to a protectedlocation when there the device detects a possible compromising 310 ofthe needle shield.

FIG. 4 is a state diagram illustration of a retractable needle inaccordance with an embodiment of the current invention. In someembodiments a drug discharge device may have an active state in which anaccess tube (for example a hypodermic needle) extends out of the device.Optionally, the device may also have a safeguarded state in which thetube is partially retracted. For example, when discharge of the drug isinterrupted in the active state, the device may automatically switch tothe safeguarded state.

In some embodiments, in active state 401, a sharp needle and/or cannulamay extend out of the device. In a safeguarded state the needle isoptionally partially retracted 404. For example, in the extended state aportion of the needle may be exposed and/or extend outside a housing ofthe device. Optionally, in the partially retracted state, a smallerportion of the needle may be exposed and or extend out of the devicethan in the exposed state. For example, in the extended state a needletip may extend a distance away from a housing of the device (for examplethe distance from the device may be operationally defined as theshortest distance between the needle point and any point on the deviceand/or as the distance between the needle point and a particularlocation for example a sensor location on the device). Optionally, inthe partially retracted state, the needle may extend away from thedevice less far than in the exposed state. Optionally the device mayhave a fully retracted state and/or an intermediate state. In thepartially retracted state the needle may be on a path between the fullyretracted state and the extended state. In some embodiments, a shieldmay cover a tip of the tube in the partially contracted state.

FIG. 5 is a state diagram illustration of a needle in accordance with anembodiment of the current invention. In some embodiments, an injectormay have an exposed state 501 and/or multiple safeguarded states. Forexample, in a first safeguarded shielded state 508, a sharp point of atube may be covered by shield protecting a user from a hazard. Thedevice may have a second safeguarded state 505. For example the devicemay revert to the second safeguarded state when there is a sign ofcompromise of protection of the first safeguarded state. For example inthe second safeguarded state 505 the tube may be retracted to a safelocation. For example, when a force is applied to the shield, the tubemay be retracted into the second safeguarded state.

FIG. 6 is a state diagram illustration of a multi position needle inaccordance with an embodiment of the current invention.

In some embodiments an injector may have a dormant 612 state. Forexample, in dormant state 612 an energy storage device (for example abattery) may be isolated, for example avoiding draining energy.Optionally in the dormant state 612, a component of the system ispositioned to be protected against damage during storage and/ortransport. Optionally in the dormant state a hazardous component (forexample a needle tip) is locked in a protected position and/or a shieldis locked around the hazardous component.

In some embodiments, the device includes a preactivated state 622. Forexample the device may enter the preactivated state 622 from a dormantstate 612. For example, the switch to the preactive state may be causedby an action of a user and/or a supplier. For example, the device mayenter the preactivated state 622 when the device is removed from apackage and/or in response to a user and/or a helper and/or a supplierand/or a medical aid switching the device on. Optionally, in thepreactivated state 622 a hazardous component is locked and/or shielded.Optionally in the preactivated state 622 a sensor is initiated.

In some embodiments a device includes a primed state 614. For example, adevice may switch from a preactivated state 622 to a primed state 614when a sensor registers that the device is ready for use (for example ithas been placed on the skin of a subject). Optionally in primed state614 a hazardous component is unlocked and/or ready for exposure. Forexample, when a preactivated device is placed on the skin of a user, askin sensor may register placement on the skin and/or unlock a needle.Alternatively or additionally, a device may not have separatepreactivated 622 and primed 614 states. For example, the device may bepreactivated and/or primed simultaneously.

In some embodiments, a device may include an activated state 601. Forexample, a user may activate a primed device, for example by pressing anactivation button. In the active state 601 a hazardous component may beexposed. For example, a needle may be extended out of a housing of thedevice. For example in the activated state 601 a drug may be dischargedthrough a tube (e.g. an extended hypodermic needle) into a subject.

In some embodiments a device may include a partially protected state604. For example at the completion of drug discharge and/or upon amalfunction and/or upon removal of the device from the skin a hazardouscomponent may be partially protected. For example a needle may beshielded and/or partially retracted. The partially protected position isoptionally stable. For example, the device may remain in the partiallyprotected state 604 until disturbed.

In some embodiment a device may include a fully protected state 605. Forexample, if there is some compromise of the protection of the hazardouscomponent in the partially protected state 604, the device may revert toa fully protected state 605. For example, if a force is applied to aneedle shield protecting a needle in a partially protected state 604,the needle may retract to a fully protected state 605. Optionally adevice may be permanently locked and/or disabled in one or both of thepartially protected state 604 and/or the fully protected state 604.

FIG. 7 is a block diagram illustration of a drug delivery system inaccordance with an embodiment of the current invention. Optionally, adevice may include a drive system 729. Optionally, drive system 729 mayexpose and/or protect a hazardous component. For example a hazardouscomponent may include a sharp needle 704. For example drive system 729may expose a sharp needle by extending it out of a housing 724. Forexample a drive system 729 may protect a sharp needle 704 by retractingit back into housing 724. In some embodiments there may be anintermediate state between a fully retraction and extension (for examplea partially retracted state). For example drive system 729 may move ahazardous component to an intermediate position and hold it there.Optionally, drive system 729 is responsive to a sensor 714. For example,drive system 729 may be connected to sensor 714 by means of anelectromechanical and/or a mechanical connection and/or through alogical component (for example a processor). In some embodiments, adrive system and/or a sensor may include an electro magnet, and/or alinear actuator and/or a piezoelectric element.

FIG. 8 is a block diagram illustration of a protection mechanism inaccordance with an embodiment of the current invention. Optionally aprotection mechanism may include a shield 814. For example, in someconfigurations shield 814 may cover and/or protect a hazardous element(e.g. a needle 704). Optionally shield 814 may be synchronized with adrive system 829. For example, needle 704 may be protected by shield 814when shield 814 is in a deployed position and needle 704 is in aretracted position and/or an intermediate position. For example, needle704 may retract when shield 814 deploys. For example, needle 704 maypartially retract when shield 814 deploys. Optionally, needle 704 isretracted into a housing 724 needle 704 and/or protected when shield 814is withdrawn and/or compromised. Optionally when shield 814 is withdrawnand/or compromised, needle 704 may retract to inside a housing 724. Forexample, a housing may surround, partially surround and/or protect aninner space. Optionally or additionally a medicine to be injected may bestored on the inside of an injector.

FIG. 9 is a perspective cutaway cross sectional illustration of amultistate needle insertion and protection system in accordance with anembodiment of the current invention. The system includes a tube (e.g. ahypodermic needle 904 with a tip 909 that is optionally sharpened)mounted on a needle retainer 901. Retainer 901 optionally moves along apath. For example the path may be defined by a cylindrical track 907between a retracted position (for example as illustrated in FIG. 9-FIG.11C) and/or an extended position (for example as illustrated in FIGS.12A-12D) optionally including an intermediate, partially retractedposition (for example, as illustrated in FIGS. 13A-13C).

In some embodiments a needle may be connected to a fluid train. Forexample, a needle may have a sharp point and/or a lumen. An opening tothe lumen may be connected to the fluid train. For example, the fluidtrain may supply a connection between the lumen of a needle and amedicine cartridge. For example, the fluid train may be connected toand/or be in fluid communication with the lumen. For example, the fluidtrain may be connected to the needle or tube on an end opposite asharpened end and/or opposite an end that is configured for contacting asubject and/or penetrating a skin of a subject.

In some embodiments, in the retracted position, needle 904 is located ina protected position. For example, in FIG. 9 a sharp tip of needle 904is pulled back behind a contact surface 925 of base 924 of the device.Optionally, in the retracted position the entire needle 904 and/or asharp tip thereof is surrounded by a housing. For example, in FIG. 9,needle 904 is surrounded by track 907.

In some embodiments a shield 914 is provided. Shield 914 optionallymoves between a deployed position and a withdrawn position. An exemplarydeployed position is illustrated in FIG. 9 wherein a portion of shield914 is extended outward from contact surface 925. Optionally in thedeployed position, a needle aperture 944 is disaligned with needle 904,for example, inhibiting extension of needle 904 past shield 914 (forexample as illustrated in FIG. 13A). Optionally when shield 914 is in awithdrawn position aperture 944 is aligned with needle 904, for exampleallowing extension of needle 904 (for example as illustrated in FIG.12C).

In some embodiments, a drive system 929 controls movement of needle 904.Optionally, drive system 929 includes an insertion mechanism. Forexample an insertion mechanism may cause a discharge tube (e.g. needle904) to move outward and/or to protrude outward from skin contactsurface 925 and/or to penetrate the skin of a subject. Alternatively oradditionally drive system 929 includes a retraction mechanism thatreturns a discharge tube backwards from a protruding position towards aposition behind contact surface 925. For example, in the embodiment ofFIG. 9 a drive system 929 includes both an insertion and a retractionmechanism.

In some embodiments, drive system 929 includes a path defining element.For example a track and/or a carriage running along the track and/or ahinge and/or an axle and/or a selective movement blocking element. Forexample drive system 929 include track 907 and a carriage that runsalong the track, for example a carriage may include a needle retainer901. Optionally, needle retainer 901 slides along an inner bore of track907 defining a linear path of movement of needle 904. For example insystem 929, track 907 has a circular bore. Optionally, rotationalignment of retainer 901 is controlled via a tab 903 of retainer 901moving along a slit 931 in track 907. Optionally slit 931 is linear tokeep retainer 901 at a fixed rotational orientation. Alternatively oradditionally, a slit may include a curve and/or a selective blockingelbow to cause rotation of a carriage and/or selectively block movementof a carriage dependent on its rotation orientation. Optionally slit 931is blocked at a bottom point to limit movement of needle retainer 901and/or to limit protrusion of needle 904. Optionally, tab 903 mayinclude an indicator of needle position. For example an optical sensormay be used to track the position of tab 903 and/or needle 904.

In some embodiments, drive system 929 includes a second track 927 andcarriage (e.g. driver 926). For example, driver 926 slides over track927 along a linear path of movement. For example, selective movementblocking element 942 selectively blocks downward movement of driver 926dependent on the rotational orientation of driver 926. Optionally, atrack may define a linear and/or a curved path of movement. In someembodiments, a needle may have a linear and/or curved path of movement.Alternatively or additionally, a needle may move on an arm mounted on apivot and/or another path determining mechanism. Alternatively oradditionally, locking and/or facilitating and/or limiting of movementmay be controlled by mechanisms other than rotational alignment. Forexample, a needle and/or needle mount and/or needle driver and/or needleretainer may include a locking mechanism with an elastic element and/ora lock (for example a barb and/or an interference element).

Optionally, drive system 929 includes one or more energy storage deviceand/or actuators and/or forcing elements. For example, drive system 929includes three forcing elements: a forced biased insertion spring 918, abackward biased shield actuator and/or retraction spring 905 and amanual actuator (for example a manual actuator may include a push button1032 as illustrated in FIG. 10). Alternatively or additionally, anactuator and/or energy storage device may include an elastic elementand/or an electrical actuator and/or a battery and/or a pressurereservoir and/or a pneumatic actuator and/or a hydraulic actuator and/ora chemical reservoir and/or a chemically reaction driven actuator.

In some embodiments, a drive system includes one or more controlelements. Optionally, control elements may include interconnected movingelements that block and/or trigger movement of a needle and/or a needleshield and/or an actuator. A control element is optionallyinterconnected to and/or responsive to a sensor. For example, controlelements may include a gear and/or a wheel and/or a friction elementand/or an interference element and/or a flange and/or a rotating elementand/or a sliding element. Alternatively or additionally, controlelements may include a switching element and/or a logical processor. Forexample, a sensor may include a mechanical sensor interlocked with amechanical control element. Alternatively or additionally, a sensor mayinclude a mechanical sensor interlocked with a logical control element,for example a transducer and/or a processor. Alternatively oradditionally a sensor may include other forms of sensors and/ortransducers for example an optical sensor and/or a pressure transducerand/or a heat transducer. Interconnections between control elements mayinclude mechanical connections, wired electrical connections, flowpaths, and/or wireless connections.

In some embodiments, drive system 929 includes interconnected controlelements. Optionally the drive elements are mechanically interlocked.For example, mechanical control elements of drive system 929 include adriver 926. For example, driver 926 may be actuated by spring 918 and/orinclude an interference element 928. For example, interference element928 interconnects between needle driver 926 and needle retainer 901. Inthe exemplary embodiment, mechanical control elements of drive system929 may be connected to and/or responsive to a mechanical skin sensor.For example, a skin sensor may include a shield 914. Optionally, shield914 is deployed outward from surface 925 by spring 905. Optionally,shield 914 is interconnected to needle retainer 901 and/or button 1032and/or driver 926. For example, mechanical control elements of drivesystem 929 including needle retainer 901 which is optionally biasedinward from surface 925 by spring 905 may be interconnected to shield914.

FIG. 10 is a perspective cutaway cross sectional illustration of amechanism holding a needle in a preactivated state in accordance with anembodiment of the current invention. In some embodiments, in thepreactivated state a sensor is activated and/or waiting to senseplacement on a surface. For example, needle shield 914 may include amechanical sensor that is deployed outward from surface 925 (for exampleas illustrated in FIG. 10). Optionally, in the preactivated state,activation button 1032 and/or needle 904 and/or driver 926 are locked inan inactivated and/or retracted state. For example, locking may inhibitpremature extension of needle 904.

In some embodiments, a skin sensor element (e.g. shield 914) isinterconnected to a control element and/or an actuator of driver system929. For example interlocking may inhibit premature needle extension.For example, shield 914 interconnects to button 1032. For example, aninterference element (e.g. a flange 1038) is integrated to shield 914.When shield 914 is in the deployed position, flange 1038 optionallyblocks downward movement of a corresponding interference element (e.g.protrusion 1040) integrated to button 1032. For example, depression ofbutton 1032 and/or activation of the device may be inhibited until thesensor detects placement on a surface.

In some embodiments, in the preactivated state, a control element isinterlocked to a path defining element. For example, an interferenceelement of driver 926 (e.g. protrusion 1036) may be interlocked to aselective blocking element 942. For example, the interlocking mayinhibit downward movement of driver 926 and/or inhibit driver 926 frompushing needle retainer 901 and/or needle 904 outward. An exemplary 3-Dform of protrusion 1036 is illustrated in more detail in FIGS. 11A and12A. Button 1032 optionally includes a transmission element (e.g. wedge1034) that transforms a force in a first direction on button 1032 to aforce in a second direction on driver 926. For example, a downward forceon button 1032 is transformed to a sideways force on protrusion 1036and/or a torque on driver 926.

In some embodiments shield 914 rotates around a pivot 1046 fordeployment away from surface 925 and/or withdrawal towards surface 925.In some embodiments, shield 914 includes an aperture. When shield 914 isdeployed aperture 944 is optionally misaligned with needle 904 such thatthe point of needle 904 is blocked by shield 914.

FIGS. 11A-11C are a perspective cutaway and cross sectionalillustrations of a needle mechanism in a primed state in accordance withan embodiment of the current invention. In some embodiments, placing apreactivated drug delivery device against a surface primes the device.For example, placing contact surface 925 against the skin causes a skinsensor to register the skin and/or prime the device. For example, in thepreactivation state, when surface 925 is placed against a surface,shield 914 is collapsed inward towards surface 925 from a deployed stateoptionally compressing spring 905 (for example as illustrated in FIG.10). For example in FIG. 11B, shield 914 is illustrated collapsed. Insome embodiment, shield 914 moves by rotation 1046 approximately 10degrees around axis. Optionally in the collapsed state the outer surfaceof shield 914 is approximately flush with surface 925. For example,collapse of shield 914 causes flange 1038 to move out of the way ofprotrusion 1040 allowing button 1032 to be depressed. Optionally,depressing button 1032 releases a control element automaticallyactivating the device. In some embodiments, rotation of a shield mayrange between 0 to 10 degrees and/or between 10 to 30 degrees and/orbetween 30 to 60 degrees and/or between 60 to 90 degrees and/or between90 to 120 degrees and/or between 120 to 180 degrees.

In some embodiments, a transmission element of an actuator is alignedwith an interference element of a control element. For example, in aprimed state, wedge 1034 of button 1032 is aligned with protrusion 1036,for example as illustrated in FIG. 11A. Optionally, depressing button1032 will push wedge 1034 against protrusion 1036. As wedge 1034 ispushed against protrusion 1036, it optionally transmits a lateral forceonto protrusion 1036. For example, the lateral force may cause a torqueon driver 926 (for example due to the force couple between the drivingforce of wedge 1034 on protrusion 1036 and the counter force of track927). The torque will optionally rotate driver 926 around track 927.Rotating driver 926 optionally disengages protrusion 1036 from blockingelement 942, for example as illustrated in FIGS. 11A-11C.

In some embodiments, rotating drive 926 aligns an interference element928 with a corresponding interference element 1130 on needle retainer901, for example as illustrated in FIG. 11C.

In some embodiments, a drug discharge device includes an upper housing.For example, a portion of an upper housing 1124 is illustrated in FIG.11B. Optionally a needle driver system may be completely surrounded bybase 924 and/or upper housing 1124.

FIGS. 12A-12D are perspective cutaway and cross sectional illustrationsof a needle mechanism in an activated and/or extended state inaccordance with an embodiment of the current invention. In someembodiments, a user activates a device from a primed state to an activestate. For example, by a user depressing button 1032, driver 926 isrotated, aligning interference element 928 of driver 926 withinterference element 1130 of needle retainer 901 and/or disengagingprotrusion 1036 from selective blocking element 942. When protrusion1036 is disengaged from selective blocking element 942, spring 918pushes driver 926 downward. As driver 926 moves downward interferenceelement 928 optionally engages interference element 1130 and/or drivesneedle retainer 901 downward and/or extends needle 904 outward.Optionally driver 926 is held down by spring 918. Optionally, whileshield 914 is in the withdrawn position and driver 926 is in theextended position, driver 926 is prevented from disengaging from needleretainer 901.

In some embodiments, in the active stage needle 904 is locked in theextended position. For example, needle 904 may extend into the skin of asubject and/or act as a fluid path for discharging the drug into thesubject. Optionally, needle 904 may be locked in the extended positionby driver 926. For example, interference element 928 may remain engagedto interference element 1130 preventing upward movement of needleretainer 901 and/or retraction of needle 904. For example, while shield914 is in the withdrawn position, shield 914 engages protrusion 1036and/or prevents driver 926 from rotating. As long as driver 926 isprevented from rotating, interference element 928 of driver 926optionally remains engaged with interference element 1130 of needleretainer 901, for example as illustrated in FIG. 12A.

In some embodiments, while shield 914 is in the withdrawn position,aperture 944 is aligned with needle 904 allowing needle 904 to extendout aperture 944 as is illustrated for example in FIGS. 12B-12C.

FIG. 12A illustrates an optional interference element (e.g. a flange1248) on needle retainer 901. Optionally, needle shield 914 includes aninterference element (e.g. a lug 1238). For example, when shield 914 isin a withdrawn position (for example as illustrated in FIG. 12C) lug1238 is not aligned with flange 1248. For example, when shield 914 is ina deployed position (for example as illustrated in FIG. 13A) lug 1238 isaligned with flange 1248.

FIGS. 13A-13C are perspective cutaway illustrations of a mechanismholding a needle in an intermediate state in accordance with anembodiment of the current invention. In some embodiments, when the base924 is removed from an injection surface (e.g. the skin of a subject),shield 914 moves outward to the deployed position. For example shield914 pivots outward around pivot 1046. Optionally outward movement ofshield 914 facilitates retraction of needle 904. Additionally oralternatively, needle may partially retract and/or be held in a stablepartially retracted position.

In some embodiments, in the active state, driver 926 is biased todisengage from needle retainer 901. For example, in the active statedriver 926 is biased to rotate by the force of spring 905 against theangled interface between interference element 928 and interferenceelement 1130. In the active state disengagement is optionally blocked byinterference between shield 914 and protrusion 1036, for example asexplained in regards to FIG. 12A and as illustrated in FIG. 15.

In some embodiments, deploying of shield 914 from a withdrawn state inan active state to a deployed state (for example by removing theinjector from the skin of a subject) unlocks needle 904 and/or orfacilitates needle retraction. Optionally, deploying shield 914 from theactive/withdrawn state frees driver 926 to rotate. For example, asillustrated in FIGS. 12A and 15, in the active state, shield 914interferes with movement of protrusion 1036 and/or inhibits rotation ofdriver 926. Optionally, as can be seen for example in FIGS. 13A and 16,when shield 914 is deployed, the body of shield 914 is distanced fromprotrusion 1036 enough to not interfere with rotation and/or to allowrotation of protrusion 1036 and/or driver 926.

Optionally, when driver 926 rotates from the active position (forexample of FIG. 15) to the partial retracted position (for example ofFIG. 16) interference elements 928 and 1130 disengage. Disengaginginterferences element 928 allows interference element 1130 and/or needleretainer 901 and/or needle 904 to move inward (e.g. retract).

In some embodiments, while shield 914, is in the deployed position,needle 904 retracts to and/or is held in the partially retractedposition. For example as illustrated in FIG. 13B, shield 914 may beintegrated to an interference element or flange (e.g. lug 1238). Whenshield 914 is deployed, interference lug 1238 optionally blocks aretraction path of needle 904. For example, lug 1238 blocks retractionof needle 904 before it reaches a fully retracted position (for examplebefore it reaches the fully retracted state illustrated in FIGS. 9-11C).For example, as needle 904 retracts flange 1248 contacts lug 1238stopping retraction in the partially retracted state. Optionally, whileshield 914 remains in the deployed state, needle 904 is held stable inthe partially retracted state.

In some embodiments, in the deployed position, shield 914 covers a tipof needle 904. For example, in the deployed position aperture 944 may bemisaligned with needle 904 (for example as illustrated in FIGS. 13A and13C). For example, in the extended and/or partially retracted position,needle 904 may block shield 914 from withdrawing from the deployedposition to the withdrawn position. Optionally, shield 914 may bepositioned very close to the tip of needle 904. For example, closepositioning of shield 914 over needle 904 may inhibit insertion of afinger between shield 914 and needle 904 may inhibit a stick hazard.

Optionally, for example as illustrated FIG. 13C, in the intermediatestate a portion of needle 904 may extend out of base 924. For example,in the intermediate state needle 904 may protrude from base 924 lessthan in the active state. Optionally, in the intermediate state theneedle may be protected, for example by shield 914.

FIG. 14 is a perspective cutaway illustration of a mechanism holding aneedle in a retracted state in accordance with an embodiment of thecurrent invention. In some embodiments, disturbing shield 914 in thedeployed position may cause needle 904 to collapse from an intermediateposition to a further and/or fully retracted position. For example whenshield 914 moves, flange 1038 may disengage from flange 1248.Disengagement of flange 1038 from flange 1248 may allow needle 904 toretract. Optionally, retraction may be driven by an actuator, forexample spring 905. Alternatively or additionally, needle 904 may befreed to retract such that collapse of shield 914 from the deployed tothe withdrawn position may push needle 904 and or further retract theneedle. For example, shield 914 is pushed towards base 924 needle 904may retract to a protected position inside of housing 1124.

FIG. 15 is a perspective cutaway illustration of a needle mechanism inan activated state in accordance with an embodiment of the currentinvention. Optionally in the activated state, needle 904 is held in anextended state by needle holder 901. For example, needle holder 901 isheld in the extended position by contact between an interferenceelements on driver 926 (e.g. interference element 928) and retainer 901(e.g. interference element 1130). In turn, driver 926 is optionally heldextended towards the base of the device by an actuator (e.g. spring918). Interference element 928 optionally is kept engaged withinterference element 1130 by interference between a protrusion 1036 ondriver 926 and shield 914 (e.g. protrusion 1040 and the portion ofshield 914 to which it is attached).

FIG. 16 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention. In some embodiments, when the device is removed froma surface, shield 914 pivots outward. Movement of shield 914 optionallyallows further retraction of needle 904. For example, pivoting of shield914 ends interference between protrusion 1036 and the extension ofshield 914. Without interference between protrusion 1036 and shield 914,driver 926 optionally rotates. For example, as illustrated in FIG. 16,rotation of driver 926 disaligns interference element 928 frominterference element 1130 optionally allowing interference element 1130and/or needle retainer 901 and/or needle 904 to retract. Optionally,needle retraction is stopped at an intermediate position for example asdescribed above with respect to FIG. 13C, by interference between flange1248 of needle retainer 901 and lug 1238 of shield 914.

FIG. 17 is a perspective cutaway illustration of a mechanism holding aneedle in an extended state in accordance with an embodiment of thecurrent invention.

FIG. 18 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention.

FIG. 19 is a perspective cutaway illustration of a mechanism holding aneedle in an intermediate state in accordance with an embodiment of thecurrent invention. In some embodiments needle shield 914 may include anaperture 944. Optionally when shield 914 is deployed, aperture 944 isdisaligned with needle 904. For example, outward movement of needle 904is blocked by shield 914 in the deployed position. Alternatively oradditionally, in the partially retracted position, needle 904 may belocked, inhibiting outward movement.

In some embodiments, base 924 includes an opening 1944. Optionally inthe withdrawn position, needle shield 914 covers opening 1944. Forexample in the withdrawn position, the outer surface of shield 914 maybe approximately flush with surface 925. Alternatively or additionally,a base may have an indentation and/or shield 914 in the withdrawnposition may fit into an indentation that does not penetrate through thebase.

FIG. 20 is a schematic illustration of dual needle shields in accordancewith an embodiment of the current invention. In some embodiments, asecond needle shield may be used to fortify a first shield againstmovement due to external forces and/or to block access to a stickhazard. For example, a primary shield 2014 a may cover a stick hazard. Asecondary shield 2014 b may prop up primary shield 2014 a and/or blockan opening between shield 2014 a and a base 2024 of the device.

In some embodiments, a primary shield may rotate around a first axis2046 a. Optionally a secondary shield may rotate around a second access2046 b. For example, shield 2014 a may lie in a withdrawn state overneedle 2004 in a retracted state and may open by movement to an acuteangle (e.g. counter clockwise in FIG. 20) overlying needle 2004.Alternatively or addition, shield 2014 a may have a withdrawn positionflat against base 2024, but not overlying the needle and/or may open(e.g. clockwise in FIG. 20) to an obtuse angle overlying needle 2004.For example, shield 2014 b may lie in a withdrawn state not overlyingneedle 2004 in a retracted state. For example needle shield 2014 b mayopen to an obtuse angle (e.g. counter clockwise in FIG. 20).Alternatively or addition, shield 2014 b may have a withdrawn positionoverlying the needle and/or may open (e.g. clockwise in FIG. 20) to anacute angle.

FIGS. 21A and 21B are schematic illustrations of needle protectionmechanism including a translating needle shields in accordance with anembodiment of the current invention. In some embodiment, a needle shieldmay include a translating part. For example a sleeve 2114 b may deployby translating parallel to the axis of a needle. For example, sleeve2114 b may deploy by translating outward from a base 2124 to cover aneedle. For example, shield 2114 b deploy at the end of delivery of adrug and/or when the device is removed from the subject. Optionallysleeve 2114 b may partially surround needle 2104. For example, as shownin FIG. 21B, shield 2114 b surrounds needle 2104 on three sides.Alternatively or additionally, a sleeve may entirely surround a needleand/or shield a needle from one side. In some embodiments shield 2114 bmay lock open. Alternatively or additionally, shield 2114 b may lock toneedle 2104. For example when shield 2114 b is locked to needle 2104,moving shield 2114 b may also move needle 2104. For example, forcingshield 2114 b inward (e.g. towards its withdrawn position) may alsoforce needle 2104 inwards and/or retract needle 2104. Alternatively oradditionally compromising shield 2114 b (e.g. applying a force to shield2114 b) may trigger automatic retraction of needle 2104. In someembodiments a system with a translating shield 2114 b may also include apivoting shield 2114 a, for example pivoting around a pivot 2146.Alternatively or additionally, a translating shield 2114 b shields aneedle without a pivoting shield. For example, shield 2114 b may bepushed downward by a spring and/or pulled down by shield 2114 a.

FIG. 22 is an illustration of a needle point protection device with aprotrusion blocking a path to a needle point in accordance with anembodiment of the current invention. In some embodiments, a protectiondevice may leave a path of access to a sharp hazard. For example, aneedle shield 2214 may deploy shielding a needle point (for example suchthat the needle point is located between shield 2214 and a housing ofthe device (for example a base 2224)). In some embodiments a gap 2291provides a path of access to the needle point and/or a path forpotential exposure to the hazard. Optionally, a protrusion (for exampleprotrusions 2293 a and/or 2293 b) blocks gap 2291. For example,protrusions 2293 a and/or 2293 b may be deployed and/or withdrawn.

In some embodiments, a protrusion may be deployed with a needle shield.For example, protrusion 2293 a is integral to and/or connected to shield2214 such that deploying shield 2214 to cover a tip of needle 904automatically deploys protrusion 2293 a to at least partially block gap2291. Optionally a channel 2244 may be provided into which protrusion2293 a fits when it is withdrawn. For example, when shield 2214 iswithdrawn, protrusion 2293 a fits into channel 2244 in base 2224.Optionally, withdrawing shield 2214 and/or protrusion 2293 a avoidsinterference by the shield with the functioning of the device. Forexample, when the device is active, shield 2214 is flush with base 2224and/or protrusion 2293 a is inserted into channel 2244 such that in thewithdrawn state shield 2214 and/or protrusion 2293 a do not interferewith contact between the outer side of base 2224 and the skin of thesubject.

In some embodiments a path to a hazardous component may be blocked by aprotrusion extending from a housing of a device. For example, protrusion2293 b at least partially blocks gap 2291. Optionally, multipleprotrusions 2293 a and 2293 b may cooperate and/or intermesh to blockgap 2291. In some embodiments, protrusion 2293 b may be withdrawable.For example, when a device is placed on the skin of a user and/or in anactive mode, protrusion 2293 b may withdraw into base 2224, facilitatingcontact between base 2224 and the skin of a user. Optionally, when thedevice is removed protrusion 2293 a deploys.

In some embodiments, a protrusion may include a sensor. Optionally,protrusion 2293 b may sense a distance between base 2224 and a skin of auser (for example the distance may be the shortest distance from thebase to a contact point on the sensor for example for shield 914 thedistance to the skin may be operationally measured as the distance fromthe distance from the far end of shield 914 [opposite pivot 1046] tobase 924 along a line perpendicular to the plane of base 924). Forexample, protrusion may be biased outward and/or be pushed inward byskin as base 2224 is placed on the skin. Optionally, a sensor (forexample a linear gauge sensor) measures the distance that protrusion2293 b protrudes from base 2224. That distance may be a measure of thedistance from a skin of the user. Optionally, protrusion withdraws whenthe device is placed straight onto skin, but locks when a force isapplied towards needle 904. For example, if a user tries to push hisfinger in to gap 2291 towards needle 904, he will push protrusion 2293 brightward. The rightward force optionally locks protrusion 2293 b in theprotruding state. For example, the protrusion 2293 b may be locked inthe protruding state by a ratchet 2297 and/or a pivot 2246. For example,pivot 2246 may be biased clockwise, disengaging ratchet 2297 unless asignificant force is applied rightward. Alternatively or additionally,pivot 2246 may allow protrusion 2293 b to collapse in one direction (forexample clockwise) which is not associated with a hazard (for example afinger penetrating gap 2291) and/or not in a second direction (forexample counter clockwise) that is associated with a finger penetratinggap 2291.

FIG. 23 is a schematic illustration of a needle protection device with alinear deploying needle shield in accordance with an embodiment of thepresent invention. Optionally a shield 2314 includes a tubular body anda locking mechanism (for example barbs 2397). Optionally, at the end ofinjection and/or when the device is removed from the skin of arecipient, an actuator (for example spring 2318) pushes shield 2314 outthrough needle hole 2344 in base 2324. For example, barbs 2397 lockshield 2314 in an extended position shielding needle 904.

FIGS. 24A-24C are schematic illustrations of a needle safeguardingmechanism in accordance with an embodiment of the current invention. Insome embodiment, a base includes a skin contact surface 2424. Optionallythe base may also include an indentation 2414. Optionally, in somestates a needle 2404 may be completely retracted into a housing of thedevice. For example, as illustrated in FIG. 24C, needle 2404 may beretracted behind base 2424 including indentation 2414. Optionally in anintermediate state, needle 2404 may project out from the inside of thehousing to outside the housing through an opening 2444 a of the base,but remain protected inside indentation 2414 on the outside of thehousing, for example as illustrated in FIG. 24A. Optionally, in a fullyextended state (for example as illustrated in FIG. 24B, the needle mayextend out beyond skin contact surface 2424 and into a skin 2487 of asubject.

In some embodiments, an injector may have a preactivated and/or a primedstate with needle 2404 in an intermediate position (for example asillustrated in FIG. 24A). For example, in a preactivated state, a tip ofneedle 2404 may be protected inside indentation 2414. Optionally in thepreactivated state the needle tip may be further protected by anadhesive cover that covers the gap in skin contact surface 2424 overindentation 2414. Alternately or additionally, a needle may initially becovered by another needle cap. For example, a conventional tubularneedle cover may be positioned over the needle. Optionally, the needlecap may be pulled off before use. Optionally the device is primed byremoving the adhesive cover and/or needle cap and placing contactsurface 2424 against skin 2487.

In some embodiments, the needle may be extended out of indentation 2414into a subject in an activated state (for example as illustrated in FIG.24B). For example, while the needle 2404 remains inside skin 2487,needle 2404 may be used to inject a drug into the subject.

In some embodiments, at the end of the activated state, needle 2404 maybe retracted. For example, when drug discharge ends and/or when thedevice is removed from skin 2487, needle 2404 is retracted to a fullyretracted position, for example as illustrated in FIG. 24C.

In some embodiments, needle 2404 may be in a fully retracted positionbefore injection. In some embodiments, needle 2404 may be retracted toan intermediate position after injection.

In various embodiments, an indentation may have various geometries. Forexample an indentation may be semi-spherical and/or conical and/or semiovoid and/or irregular in shape. For example an indentation may have oneor more axis of symmetry. In some embodiments, an indentation mayintersect an edge of the device and/or be open one or more sides.Optionally the depth of an indentation (for example the height ofindentation 2414 in the direction of the axis of needle 2404) may rangebetween 0.1 mm to 1 mm and/or 1 mm to 3 mm and/or 3 mm to 8 mm and/ormore than 8 mm. The a width of an opening 2444 b of indentation 2414 ata skin contact surface may range for example between 0.1 to 1 mm and/orbetween 1 to 5 mm and/or between 5 to 10 mm and/or from 10 to 30 mmand/or more. The a width of a needle hole (for example opening 2444 aand/or 944) may range for example between 0.1 to 1 mm and/or between 1to 5 mm and/or between 5 to 10 mm and/or from 10 to 30 mm and/or more.

FIGS. 25A-25B are schematic illustrations of a rack and pinion needlesafeguarding mechanism in accordance with an embodiment of the presentinvention. Optionally, during injection an opening 2544 in a slidingshield 2514 is aligned with an opening 1944 in a base 2524 of a device.For example, a rack and pinion system 2546, optionally including a oneway ratchet, slides shield 2514 when a pivoting shield 2514 opens (forexample when the device is removed from the skin of a user) shield 2514slides dis-aligning openings 1944 and 2544 and/or locking needle 904into a housing. In some embodiments a rack and pinion system may unlocka needle before deployment and/or close onto (to bend and/or twistand/or break a needle after drug discharge).

FIGS. 26A, 26B and 26C illustrate an exemplary embodiment of a needlemechanism in accordance with an embodiment of the present invention.Optionally a needle mechanism has redundant protection. For example, aneedle shield may protect a needle tip from becoming a stick hazard.Alternatively or additionally, the needle tip may be retracted to aprotected location. Alternatively or additionally, a sensor may preventextension of needle until the device has been properly primed and/orpositioned on an injection zone. Alternatively or additionally, a needleshield may protect (for example by shielding) the needle tip when theneedle is extended. Alternatively or additionally, the needle tip may beretracted to a protected location when the needle shield is compromised.In some embodiments, a single part may serve multiple functions. Forexample, a needle shield may also serve as a sensor for facilitatingextension and/or retraction of the needle.

FIG. 26A is a perspective view of a needle mechanism in a preactivatedlocked state in accordance with an embodiment of the present invention(optionally as described for example in FIG. 6 state 622). Optionally ahollow needle 2604 (for example as illustrated in FIG. 26C) is connectedon one end to a drug reservoir (for example by a flexible tube 2659alternatively or additionally a needle may be directly attached to areservoir for example to a syringe). The needle 2604 optionally includesa sharp tip 2609 at an end opposite from the reservoir.

In some embodiments, depressing an activation button 2632 causes needletip 2609 to extend out of the device. For example, when the device is inthe preactivated state and/or when the device is attached to the skin ofa subject the activation. For example, activation may include the needletip 2609 piercing the skin of a subject and/or the hollow of needle 2604may form a fluid pathway between the drug reservoir and the subject.

In some embodiments, in the preactivated, locked state, tip 2609 isshielded by a housing of the device. For example, tip 2609 is supportedon an inner side 2623 of a wall (for example base 2624) of the housing.Optionally a safety latch 2638 of a skin sensor 2614 locks button 2632in an un-depressed position inhibiting premature extension of tip 2609and/or preventing a stick hazard. For example, when skin sensor 2614 isextended out from an outer surface 2625 of base 2624, latch 2638 mayblock movement of an interference element 2640 and/or latch 2638 mayblock depressing of button 2632.

FIG. 26B is a perspective view of a needle mechanism in a primedunlocked state in accordance with an embodiment of the present invention(optionally as described for example in FIG. 6 state 614). In someembodiments, when the outer surface 2625 of base 2624 is pushed againstthe skin of a subject (for example at an injection site), sensor 2614 ispushed upwards towards base 2624. Optionally, pushing sensor 2614towards base 2624 causes sensor 2614 and/or latch 2638 to pivot around ahinge 2646. Pivoting optionally moves latch 2638 out of the way ofinterference element 2640 and/or facilitates depressing button 2632.

In some embodiments, depressing button 2632 triggers an automatic needleinsertions mechanism for example as illustrated in FIG. 26C to FIG. 28C.Alternatively or additionally, force on button 2632 directly pushesneedle 2626. For example, needle 2604 may be rigidly attached to button2632 and/or move therewith.

FIG. 26C is a cutaway view of a needle mechanism in accordance with anembodiment of the current invention. In some embodiments, a needlemechanism may include one or more stored energy sources. Stored energymay be used for needle extension, protection and/or for sensing.Optionally, one or more components of a needle retraction system willserve different functions depending on the state of the system.Optionally, the needle retraction system movable mounts needle 2604 ahousing (for example a base 2624). For example, the needle mechanism maymovably connect needle 2604 to base 2624. For example, a tip 2609 of aneedle 2604 may move longitudinally with respect to the housing. Forexample, a sharp tip 2609 may move through a needle hole 2644 to beexposed and/or protected, for example as described herein below.

In some embodiments, needle extension, retraction and/or shielding maybe driven by a stored energy source. For example, a compression spring2618 may drive the needle extension. For example, a second countercompression spring 2605 may drive needle retraction. For example, atorsion spring 2647 may drive deployment of a skin sensor 2614.Optionally sensor 2614 may serve multiple functions at different statesof the system. For example, sensor 2614 may act as a skin sensor tounlock needle extension when the device is placed on an injection site.For example, sensor 2614 may act as a needle shield protecting a sharpneedle point after the end of drug delivery and/or while the needle isextended. For example, sensor 2614 may act as a trigger needle forretraction. Optionally, a single stored energy device may drive multiplemovements. For example, a single torsion spring may drive a wheelwherein a first half turn causes needle extension and a second half turncauses needle retraction and/or a compression spring may pull a pinalong a track which moves the needle first to the extended position andsubsequently back to the retracted position.

In some embodiments, sensor 2614 may be mechanically interlocked with aneedle extension mechanism (for example button 2632 as illustrated forexample in FIGS. 26A and 26B). For example, the interlock may unlock aneedle extension mechanism when the injector in a locked preprimed stateis placed on an injection site, for example as explained in reference toFIGS. 26A and 26B.

In some embodiments, sensor 2614 may shield a needle. For example, afterdrug delivery and/or when the delivery device is removed from theinjection site, sensor 2614 may be deployed to shield a needle (asillustrated for example in FIGS. 29A-29C and/or in connection to ashielded state in FIG. 5 and/or in connection to a partially protectedstate and/or in connection to FIGS. 13A-13C).

FIGS. 27A to 27C illustrate a needle assembly in a primed state inaccordance with an embodiment of the current invention. In someembodiments, a skin contact surface on an outer surface 2625 of theinjector is adhered to the skin of a subject. Optionally, placing theskin contact surface onto the skin forces pushes sensor 2614 and/orpivots it upward around pivot 2646. Optionally, sensor against movesupward until is rests against and/or is flush to outer surface 2624.Optionally, as sensor 2614 pivots upward, safety latch 2638 pivots awayfrom activation button 2632, freeing button 2632 to move downward.Optionally, freeing button 2632 to move downward, primes the device.

FIG. 27B illustrates a needle insertion mechanism in a primed state inaccordance with an embodiment of the present invention. In someembodiments, needle insertion may be powered by stored energy in thedevice. For example, spring 2618 pushes downward on a needle holder 2601rigidly connected to the needle 2604. In the primed state, the needle2604 is optionally locked in a retracted position by a pin 2736 in atrack 2707 b. A slanted track 2742 b in button 2632 optionally controlsthe horizontal position of pin 2736. As button 2632 is depressed(vertically downward) pin 2736 is optionally forced by slanted track2742 b leftward (e.g. by rotating needle holder 2601).

FIG. 27C illustrates a needle retraction mechanism in a primed state inaccordance with an embodiment of the present invention. In someembodiments, needle retraction may be powered by stored energy in thedevice. For example, spring 2605 (for example as illustrated in FIG.26C) pushes upward on a retraction slider 2626. Slider 2626 optionallyincludes two pins 2738 and 2740. In the primed state, slider 2626 isoptionally locked in a pre-retracted position by a pin 2740 in a track2707 a. A slanted track 2742 b in button 2632 optionally controls thehorizontal position of pin 2736. As button 2632 is depressed (verticallydownward) a second pin 2738 is optionally forced by slanted track 2742 arightward (rotating slider 2626 and/or pin 2740 rightward).

FIGS. 28A to 28C illustrate a needle assembly in an activated state inaccordance with an embodiment of the current invention. In someembodiments, a user depresses an activation button 2632 to activate thedevice. For example, as illustrated in FIG. 28B, when button 2632 isfully depressed, track 2742 b has forced pin 2736 leftward until it hasreached a vertical portion of track 2707 b. In some embodiments, oncepin reaches the vertical portion of track 2707 b, it is free to movedownward, unlocking downward movement of needle holder 2601. Optionally,once unlocked needle holder 2601 and needle 2604 are pushed downward byexpanding spring 2618. Downward movement optionally extends sharp tip2609 (illustrated for example in FIG. 26C) of needle 2604 out openings944 and 2644 in base 2624 and/or shield 2614 respectively.

In some embodiments, needle tip 2609 is extended out of opening 2644 ofbase 2624 and/or opening 944 of sensor 2614 while outer surface 2625 ofbase 2624 is adhered to a skin of a subject. Optionally, an opposite endof needle 2604 remains in fluid connection with a medicine reservoirinside the housing of the delivery device. For example the hollow ofneedle 2604 becomes a fluid path for injecting a drug from the reservoirinto the subject.

FIG. 28C illustrates a needle retraction mechanism in an active state inaccordance with an embodiment of the current invention. Optionally, whenthe device is activated (for example by depressing activation button2632) the retraction mechanism is moved to an armed mode, ready toretract. For example, pin 2740 is moved close to its unlocked position,the vertical portion of track 2707 a. Alternatively or additionally, aretraction mechanism may be armed and/or further armed to a ready toretract configuration when the device is removed from the skin forexample when skin sensor 2614 is deployed (for example as illustrated inFIGS. 29A-C).

In some embodiments, a lock of the retraction mechanism is amechanically linked to skin sensor 2614. For example, pin 2740interferes with an arm 2737 of skin sensor 2614. For example, in FIG.28B it is seen that in the active state, pin 2640 contacts a arm 2737 ofsensor 2614 and/or elastically deforms arm 2737 outward.

FIGS. 29A-29C illustrate a needle retraction mechanism in a partiallyprotected state in accordance with an embodiment of the currentinvention (for example as described in state 605 of FIG. 6 and/or step308 of FIG. 3). Optionally, in the partially protected state, needle2604 remains in an extended state and/or sensor 2614 is deployed toshield sharp tip 2609. Optionally, a skin sensor is deployed when adelivery device is removed from delivery site. For example, sensor 2614pivots around pivot 2646 such that sensor 2614 covers the sharp tip 2609that passes through aperture 944 which is moved out of alignment withsharp tip 2609.

FIGS. 30A-30C illustrate a needle retraction mechanism in a fullyprotected state in accordance with an embodiment of the currentinvention (for example as described in state 604 of FIG. 6 and/or step305 of FIG. 3). Optionally, in the fully protected state sharp tip 2609has retraced behind outer surface 2625 (for example into opening 2644).Alternatively or additionally, in the fully protected state a sharp tipretracts behind the surface 2625.

In some embodiments, when a needle shield is compromised, a needle isretracted. For example, when skin sensor 2614 is moved from thepartially protected state shielding sharp tip 2609 towards housing 2624(for example, pivoting upward around pivot 2646) arm 2737 pushes pin2740 into the vertical portion of track 2707 a unlocking needleretraction slider 2626. When slider 2626 is unlocked, it is optionallymoved automatically away from opening 2644. For example, spring 2605expands pushing up slider 2626, needle holder 2601 and/or needle 2604.Optionally, the upward movement also moves sharp tip 2609 into theretracted position and/or a fully protected state. Alternatively oradditionally, retraction may not be automatic. For example retractionmay be driven by a force, for example an upward force of sensor 2614 onneedle tip 2609 and/or holder 2601 and/or slider 2626.

It is expected that during the life of a patent maturing from thisapplication many relevant technologies will be developed and the scopeof the terms are intended to include all such new technologies a priori.

As used herein the term “about” refers to ±5%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

What is claimed is:
 1. A needle insertion and retraction mechanism foran injector having a housing with a base defining an opening, the needleinsertion and retraction mechanism comprising: an injection needlemounted to a needle retainer, the needle retainer being linearlyslidable along a first track between a retracted position, in which atip of the injection needle is within the housing, and an extendedposition, in which the tip of the injection needle projects outward fromthe housing through the opening; a shield defining a needle aperture andhaving an interference element extending therefrom, the shield beingmovable relative to the housing between a deployed position, in whichthe needle aperture is misaligned with the injection needle and awithdrawn position, in which the needle aperture is aligned with theinjection needle; a retraction spring engaged with the needle retainerat one end and engaged with the shield at an opposing end, theretraction spring applying a first biasing force to the needle retainerin a first direction and a second biasing force to the shield in asecond direction; a driver engageable with the needle retainer, thedriver being linearly slidable along, and rotatable about, a secondtrack, the driver being slidable by a main spring, the main springproviding a biasing force in a direction opposite the first biasingforce of the retraction spring; and an activation button depressible torotate the driver about the second track into engagement with the needleretainer; wherein: in a pre-activation state of the insertion andretraction mechanism before the injector is placed on a skin surface ofa patient, the second biasing force of the retraction spring orients theshield in the deployed position, in which the interference elementblocks downward movement of the activation button, locking the needleretainer and the injection needle in the retracted position, and theretraction spring is in an expanded configuration and the main spring isin a compressed configuration; in a primed state of the insertion andretraction mechanism, the injector is placed on the skin surface of thepatient and the shield is moved to the withdrawn position thereof, inwhich the retraction spring is partially compressed and the interferenceelement ceases blocking downward movement of the activation button; inan activation state of the insertion and retraction mechanism, theactivation button is depressed, engaging the driver with the needleretainer and freeing the main spring to push the driver and the engagedneedle retainer and the injection needle into the extended position,thereby further compressing the retraction spring; and in anintermediate state of the insertion and retraction mechanism after theinjector is removed from the skin surface of the patient, the driver isdisengaged from the needle retainer, and the retraction spring partiallyexpands and returns the shield to the deployed position, in which theshield restricts the needle retainer from returning to the retractedposition and covers the tip of the injection needle, and whereinsubsequent contact with the shield toward the withdrawn positionreleases the needle retainer, whereby the retraction spring furtherexpands and retracts the needle retainer and injection needle.
 2. Themechanism of claim 1, wherein the tip of the injection needle ispositioned between said shield and said housing in the intermediatestate.
 3. The mechanism of claim 1, wherein said contact with the shieldtoward the withdrawn position in the intermediate state comprisesexerting a force of at least 1 Non said shield.
 4. The mechanism ofclaim 3, wherein said force is at least partially directed toward saidhousing.
 5. The mechanism of claim 1, wherein said shield is pivotallymounted on said housing and in the deployed position said shield ispivoted away from said housing.
 6. The mechanism according to claim 1,wherein said shield is flush with said housing in the withdrawnposition.
 7. The mechanism of claim 1, wherein said shield is biasedtoward said deployed position by the retraction spring.
 8. The mechanismof claim 1, wherein the retraction spring maintains the needle retainerin the retracted position at one end and the shield in the deployedposition at the other end, in a fully expanded configuration of theretraction spring.
 9. The mechanism of claim 1, further comprising ablocking element and wherein the driver includes a protrusion, andwherein, in the compressed configuration of the main spring, theprotrusion of the driver is abutted by the blocking element, maintainingthe main spring in the compressed configuration and inhibiting downwardmovement of the driver.
 10. The mechanism of claim 9, wherein theactivation button includes a wedge element configured to transform aforce in a downward direction on the button to a force in a sidewaysdirection on the driver.
 11. The mechanism of claim 10, whereindepressing the activation button in the activation state pushes thewedge against the protrusion of the driver and transmits a lateral forceonto the protrusion, causing a torque on the driver which rotates thedriver around the second track, disengaging the protrusion from theblocking element and freeing the main spring.
 12. The mechanism of claim11, wherein the driver comprises an element and the needle retainercomprises a corresponding interference element, and wherein rotating thedriver linearly aligns the element of the driver with the correspondinginterference element of needle retainer, thereby linking linear downwardmovement of the driver and the needle retainer.